BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML

    MDR report key: 7059397 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00408
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 20, 2015
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS RETURNED THAT SUPPORTED THE COMPLAINT, THE VISUAL INSPECTION SHOWED MISSING GEL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5201694 CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML HAD GEL MISSING IN 17 OF THE TUBES. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841369 BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML BLOOD COLLECTION TUBES JKA BECTON, DICKINSON & CO., (BD) 5201694

    Patients

    Seq Age Sex Outcome Treatment
    1 Other